G1 Therapeutics announced preliminary anti-tumor efficacy and myelopreservation data from its randomized, open-label Phase 2 trial evaluating trilaciclib in combination with chemotherapy as a treatment for metastatic triple-negative breast cancer, or mTNBC. These data will be presented on Wednesday, December 5 at a poster discussion Spotlight Session at the 2018 San Antonio Breast Cancer Symposium, or SABCS, being held in San Antonio, Texas.

G1 Therapeutics announced "positive" topline data from its randomized, double-blind, placebo-controlled Phase 2 trial evaluating trilaciclib in combination with chemotherapy and the checkpoint inhibitor Tecentriq as a treatment for first-line small cell lung cancer, or 1L SCLC. Trilaciclib is a myelopreservation therapy designed to improve outcomes of patients who receive chemotherapy by preserving hematopoietic stem and progenitor cell, or HSPC, and immune system function. Data from this randomized, double-blind, placebo-controlled Phase 2 trial demonstrated that trilaciclib reduced clinically relevant consequences of myelosuppression versus placebo when administered in combination with chemotherapy and Tecentriq across three lineages: neutrophils, red blood cells, or RBCs, and platelets. Lymphocyte subset analyses are ongoing. Trilaciclib was well tolerated, with no Grade 4 trilaciclib-related treatment emergent adverse events, or TEAEs, reported. Trilaciclib's potential to preserve immune system function during chemotherapy may enhance overall survival, or OS, in this trial. OS data are immature and will be reported when available. There was no statistical difference between the trilaciclib and placebo groups in overall response rate and median duration of response, or DOR. Preliminary median progression-free survivall was 5.7 months for trilaciclib versus 5.4 months for placebo.

G1 Therapeutics announced data from new analyses of its randomized Phase 2 clinical trial of trilaciclib in combination with etoposide/carboplatin for the treatment of first-line small cell lung cancer. The analyses demonstrated clinically meaningful improvements for neutrophil, red blood cell and lymphocyte measures in patients treated with trilaciclib compared to placebo. With regard to lymphocytes, trilaciclib preserved or improved B cell and T cell subset counts, including activated CD8+ cells, and increased CD8+/regulatory T cell and activated CD8+/regulatory T cell ratios in peripheral blood compared to placebo. The company reported topline data from this trial in March 2018 showing robust myelopreservation benefits of trilaciclib. Consistent with previously reported results, new analyses demonstrated that trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Overall, there were fewer greater than or equal to Grade 3 treatment emergent adverse events with trilaciclib compared to placebo, mostly due to lower number of greater than or equal to Grade 3 hematologic TEAEs.

G1 Therapeutics announced that new data from its randomized Phase 2 clinical trial of trilaciclib in combination with etoposide/carboplatin for treatment of first-line small cell lung cancer, or SCLC, will be presented at the European Society for Medical Oncology, or ESMO. The company reported topline data from this trial in March showing myelopreservation benefits. Additional data from this trial have been selected for a poster discussion session on October 21. A second poster with new data focused specifically on the impact of trilaciclib on immune system function, including preservation of T cell subsets such as activated CD8+ T cells and an increased CD8+/regulatory T cell ratio in peripheral blood compared to placebo, will be presented on October 20.

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